FDAMA Plan Appendices

Introduction

These appendices and corresponding Internet resources provide direct access to information being used within FDA to implement the FDA Modernization Act. The actual text of the law passed by Congress, verbatim comments from stakeholders related to improving the way FDA conducts business and the current implementation plan are available for review and comment.

Considerable space is devoted to stakeholder participation. Even so, only a fraction of the information is attached--the balance of information has been organized on FDA's Web site -- anyone can navigate through the wealth of FDAMA-related materials currently available.

The text of the FDA Plan for Statutory Compliance is located on the Internet at www.fda.gov/oc/fdama/fdamapln/default.htm. Additional questions or comments or requests for printed copies of these Appendices may be directed to the Planning and Management Communications Staff by telephone at 301-827-5207 or by FAX to 301-827-5225.

Appendix A: Statutory Authority

Note: Section 406 of the FDA Modernization Act amends, and has been incorporated into, Section 903 of the Federal Food, Drug, and Cosmetic Act. Copies of both sections have been included here. They include FDA's current mission and annual reporting requirements.

Appendix B: Stakeholder Involvement in 1998

Note: Involving stakeholders in modernizing the way FDA meets its statutory and public health responsibilities is perhaps the most significant advancement addressed in FDAMA. In 1998 FDA made dramatic progress in gathering ideas for improving the Agency's effectiveness. Stakeholders include experts in science, medicine, and public health, as well as consumers, product manufacturers, importers, and retailers. Most of the information contained in this section is also available on FDA's website.

Appendix C: FDAMA Implementation Chart

Note: This chart shows FDA's current status on implementing FDAMA. It provides a section-by-section overview including a brief description of each task, statutory deadlines, and key contacts within the Agency. This is the actual implementation framework used by the Agency.

Appendix D: Application and Submission Review

Note: This report includes a summary of 32 of FDA's most important functions as they relate to applications from manufacturers. Examples of these requirements are, "Review priority New Drug Applications within 6 months," and "Review infant formula notifications within 90 days." Also included are statistics that show current performance levels, future targets, and overdue applications. Other applications and submissions are also identified.

Other Information Resources Available via Internet

FDA's Web site includes a special section on the FDA Modernization Act of 1997. Various reports, meeting summaries, stakeholder comments, and implementation updates are available continuously for persons with Internet access. Visitors can learn more about FDA as well as view first-hand the Agency's progress in achieving its mission.

Full text of FDAMA, Public Law 105-115

Transcripts of public meetings

Federal Register Notice of 9/14/98 public meeting

FY 1999 Performance Plan

Department of Health and Human Services (DHHS) main Web site

horizontal rule